The E. histolytica ELISA test is a qualitative enzyme immunoassay for the detection of antibodies to E. histolytica, in samples of human serum or plasma.
E. Histolytica IgG ELISA - EIA-3474
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Entamoeba histolytica in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Entamoeba histolytica, the parasitic protozoan associated with amoebiasis.
Environmental Conditions
No Data Available
Device Sizes
- Positive Control
- Stop Solution
- Chromogen TMB
- Total Volume: 11 Milliliter
- Total Volume: 1 Milliliter
- Total Volume: 30 Milliliter
- Enzyme Conjugate
- Total Volume: 25 Milliliter
- Negative Control
- Wash Concentrate
- Dilution Buffer
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: KHW
Device Name: Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 866.3220
Third Party Flag: N
Medical Specialty: MI
Device IdentifiersDevice Id: 00840239034748
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A